FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
INTEGRA MESHED BILAYER WOUND MATRIX
K Number: K081635
·
Decision Dec 4, 2008
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
155
Applicant Total
25
Review Days
176
Basic Information
- Device Name
- INTEGRA MESHED BILAYER WOUND MATRIX
- K Number
- K081635
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INTEGRA LIFESCIENCES CORP.
- Date Received
- June 11, 2008
- Decision Date
- December 4, 2008
- Product Code
- KGN
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGN), ordered by most recent decision date.
GeniPhys Collymer Self-Assembling Scaffold
FDA 510(k)
FDA Unclassified
·Unknown
CollOvine Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
DermiSphere Dermal Template
FDA 510(k)
FDA Unclassified
·Unknown
Bovine Dermis Collagen Dermal Matrix
FDA 510(k)
FDA Unclassified
·Unknown
BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
FDA 510(k)
FDA Unclassified
·Unknown
Corplex P/ Theracor P/ Allacor P
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by INTEGRA LIFESCIENCES CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K150682 | CUSA Excel+ | Dec 18, 2015 | Substantially Equivalent |
| K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs | Apr 16, 2015 | Substantially Equivalent |
| K131184 | INTEGRA LICOX PTO2 MONITOR | Aug 30, 2013 | Substantially Equivalent |
| K092227 | JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS | Feb 17, 2010 | Substantially Equivalent |
| K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM | Nov 19, 2009 | Substantially Equivalent |
| K081401 | MAYFIELD MR/X-RAY SKULL CLAMP | Oct 8, 2008 | Substantially Equivalent |
| K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | Oct 10, 2007 | Substantially Equivalent |
| K072207 | DURAGEN XS DURAL REGENERATION MATRIX | Aug 23, 2007 | Substantially Equivalent |
| K063124 | INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS | Jan 19, 2007 | Substantially Equivalent |
| K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | May 10, 2006 | Substantially Equivalent |